Echo Detection of Endoscopic Retrograde Cholangiopancreatography (ERCP) Air Embolus
This study is currently recruiting participants.
Verified March 2012 by University of Nebraska
Sponsor:
University of Nebraska
Information provided by (Responsible Party):
Nicholas Markin, University of Nebraska
ClinicalTrials.gov Identifier:
NCT01535248
First received: August 8, 2011
Last updated: March 13, 2012
Last verified: March 2012
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Purpose
Endoscopic retrograde cholangiopancreatography (ERCP) is an endoscopy technique to visualize and evaluate the pancreatic and biliary systems. It has been reported that rare instances of air embolus have been found associated with the performance of an ERCP and many of these events are fatal. It is our proposal to use transthoracic echocardiography to continuously evaluate for the presence of intra-cardiac air secondary to ERCP venous air embolism and attempt to quantify the incidence of this complication and any potential patient factors that might increase the risk of this complication.
| Condition | Intervention |
|---|---|
|
Air Embolism as A Complication of Medical Care |
Other: Transthoracic Echocardiography |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Cross-Sectional |
| Official Title: | Echocardiographic Surveillance of Patients Undergoing Scheduled Endoscopic Retrograde Cholangiopancreatography for the Presence of Intracardiac Air Embolus |
Resource links provided by NLM:
Further study details as provided by University of Nebraska:
Primary Outcome Measures:
- Incidence of ERCP associated air embolism [ Time Frame: Participation will be for one day, during the time of the ERCP ] [ Designated as safety issue: Yes ]Patients who are scheduled for ERCP as part of their routine care will be assessed for the presence of air embolus, both clinically relevant (in the form of hemodynamic changes) and those situations where air is identified and does not appear to have a clinical effect. This is scheduled to occur over one day's time and only during the procedure are we planning on performing the echo for surveillance of air emboli.
Secondary Outcome Measures:
- Risk Factors associated with ERCP air embolus [ Time Frame: Participation will be for one day, during the time of the ERCP ] [ Designated as safety issue: Yes ]If it is found that there is a significant number of individuals that are found to have ERCP associated air embolus it would be a secondary goal to attempt to identify patient factors that might confer additional risk of air embolus to the patient.
| Estimated Enrollment: | 200 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | May 2015 |
| Estimated Primary Completion Date: | May 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
All ERCP Patients
All patients that will be approached for this study will be undergoing ERCP as part of their medical care.
|
Other: Transthoracic Echocardiography
Patients undergoing ERCP will have surveillance with transthoracic echocardiography with exams occurring every 10 mins or more often if needed to evaluate for the presence of intra-cardiac air associated with ERCP insufflation.
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
The Study Population will be all subjects who are scheduled to undergo ERCP and consent to participate in the protocol. No exclusions will be made based on gender or race to provide for a particular distribution, all subjects who would like to participate will be included.
Criteria
Inclusion Criteria:
- Subject is undergoing ERCP as part of their medical care
- Subject will be of age 19 or older
Exclusion Criteria:
- Subject positioning for the ERCP is prone, thereby inhibiting the performance of the TTE
- Subject intolerance of the pressure of the TTE probe
- Subject body habitus interferes with obtaining adequate images to assess for intra-cardiac air
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01535248
Locations
| United States, Nebraska | |
| The Nebraska Medical Center | Recruiting |
| Omaha, Nebraska, United States, 68198 | |
| Contact: Nicholas W Markin, MD 402-559-4081 nmarkin@unmc.edu | |
| Contact: Candice R Montzingo, MD, FASE 402.559.4081 cmontzin@unmc.edu | |
| Principal Investigator: Nicholas W Markin, MD | |
| Sub-Investigator: Candice R Montzingo, MD, FASE | |
| Sub-Investigator: Grant F Hutchins, MD | |
Sponsors and Collaborators
University of Nebraska
Investigators
| Principal Investigator: | Nicholas W Markin, MD | University of Nebraska |
More Information
No publications provided
| Responsible Party: | Nicholas Markin, Chief Resident, Department of Anesthesiology, University of Nebraska |
| ClinicalTrials.gov Identifier: | NCT01535248 History of Changes |
| Other Study ID Numbers: | 238-11-FB |
| Study First Received: | August 8, 2011 |
| Last Updated: | March 13, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Nebraska:
|
ERCP Transthoracic Echocardiography Air Embolus ERCP associated air embolus |
Additional relevant MeSH terms:
|
Embolism Embolism, Air Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 19, 2013